Dispensing apparatus and cartridge

ABSTRACT

A device for the treatment of periodontal disease includes a handle that has a configuration familiar to dental professionals, and a cartridge, that is locked into the handle when use, typically delivery of a composition to a periodontal pocket is desired. The cartridge provides for effective delivery of compositions, such as agents, as its tip is deformable, typically from a circular to an oval shape so as to flatten. The deformation may be made, either manually, by the dental professional, or upon contact with teeth or other tissues, whereby this flattened tip can penetrate deeply into periodontal pockets for quick and direct application of the composition, for example, therapeutic agents.

TECHNICAL FIELD

[0001] The present disclosure is directed to apparatus, components, andmethods of treatment for periodontal disease.

BACKGROUND

[0002] Periodontal disease is an umbrella term for a variety of dentalconditions associated with either gingivitis or periodontitis.Gingivitis is an inflammation of the gingiva, commonly known as gums,that is commonly associated with poor oral hygiene and/or the hormonalstate of the patient. If left untreated, gingivitis may develop intoperiodontitis.

[0003] Periodontitis is a bacterial disease in which the infection hasprogressed to involve the oral tissues that retain the teeth in thejawbone. With this disease the gums become red and inflamed. Thiscondition, if untreated, results in damage to the ligaments and boneholding the teeth in place, and formation of pockets around the teeth.As the pockets become deeper, teeth loosen, to a point where they mayfall out. The severity of periodontitis is determined by dentists andother dental practitioners, by measuring the depth of these pockets andreviewing x-rays of the teeth and jawbone.

[0004] Periodontal disease involves a different treatment protocol thanother oral diseases. While many oral diseases can be treated with properhygiene, fluoride, pastes, washes and rinses, periodontal disease isoften more refractile to treatment. This is because of differencesbetween the oral and periodontal cavities. The oral cavity isessentially an aerobic environment, constantly perfused by saliva. Incontrast, the periodontal cavity is more anaerobic, and is perfused byplasma filtrate, known as “crevicular fluid.” The growth ofmicroorganisms within the periodontal cavity microenvironment may causeperiodontal disease. As the disease progresses, the periodontalmicroenvironment becomes more anaerobic, and the flow of crevicularfluid increases.

[0005] Efforts to treat periodontal disease have met with limiteddegrees of success. This is because the site of the bacterial infectionsin the periodontal cavity are largely inaccessible to agents present inthe oral cavity as well as agents provided to the oral cavity, such asmouthwashes, rinses and the like. Moreover, the increased outflow ofcrevicular fluid that accompanies periodontal disease inhibitstherapeutic agents placed into the oral cavity from entering thepockets.

[0006] Oral systemic administration of antibiotics has been shown to bea useful method of controlling subgingival flora. However, because ofside effects, such as those of the digestive system, oral systemicadministration has had only limited use in treating periodontal disease.Oral systemic therapy also requires frequent dosing, so patientcompliance is frequently a problem.

[0007] Recently, efforts have focused on delivering therapeutic agentsdirectly to these pockets, in some cases, in a controlled releaseformulation. In general, administration of agents directly to the pocketpermits higher local drug concentrations that can be achieved bysystemic administration. Also, some agents such as tissue growth factorsmust be administered directly to the target site, i.e., the periodontalpocket. Also, as these products are typically administered by dentalprofessionals patient compliance is not of moment here.

[0008] U.S. Pat. No. 4,175,326 to Goodson discloses the use of adrug-filled polymer hollow fiber. The disclosed delivery system is tiedaround a tooth and gently pressed below the margin of the gingiva sothat it resides in the periodontal pocket, and can deliver tetracyclinefor a prolonged period, such as a week or more.

[0009] Although these devices may be able to dispense and appropriatedrug for a time span of a week or more, they have not been widely used.This is because their application is difficult and time consuming andthe device may be dislodged by the patient during tooth brushing,flossing or eating.

[0010] The aforementioned disadvantages were overcome by administrationof microparticles in dry form to the periodontal pocket by use of anapparatus disclosed in U.S. Pat. Nos. 5,236,355, 5,366,733 and5,622,498, all to Brizzolara, et al., all three patents are incorporatedby reference herein. These patents disclose treating dental diseases byadministration of dry microparticles to the periodontal pocket.Microparticles suitable for this purpose may have compositions, asdescribed in U.S. Pat. Nos. 5,000,886, 5,143,661 and 5,500,228, all toLawter, et al., all three of these patents incorporated by referenceherein, and U.S. Pat. Nos. 5,236,355, 5,366,733 and 5,622,498, all toBrizzolara, et al., and may be produced by the methods disclosed in theaforementioned six U.S. patents.

SUMMARY

[0011] The apparatus, components and methods disclosed herein improve onthe contemporary art by providing a dispensing apparatus that caneffectively deliver therapeutic agents directly to the periodontalpockets. The apparatus disclosed herein includes a reusable handle thatis fitted with disposable cartridges, loaded with a composition, forexample, a precise dose of a therapeutic agent. This saves the cliniciantime, eliminates guessing as to the proper dose, and reduces the amountof disposable instrumentation, making the process more economical.Additionally, the handle includes a body that has a configurationfamiliar to dental professionals, allowing them to use the disclosedapparatus with greater comfort and less training time. The cartridgeprovides for effective delivery of compositions, such as agents, as itstip is deformable, typically from a circular to an oval shape, eithermanually by the dental professional or upon contact with teeth or othertissues, whereby this flattened tip can penetrate deeply into pocketsfor quick and direct application of therapeutic agents.

[0012] An embodiment disclosed is directed to an apparatus fordispensing at least one material to a periodontal pocket. The apparatushas a barrel including a body portion and a tube portion, the tubeportion extending from the body portion and including a tip configuredfor being deformed to at least one geometry different from its initialgeometry. There is also a plunger, at least a portion of the plungerslideably housed within the barrel, the plunger configured forcontacting a portion of an external force applying member. Additionally,there is a quantity of dry particles, for example a composition such asa therapeutic agent(s) or the like, and at least a portion of the dryparticles are within the tip. A cap or closure member may be fitted overthe tip to maintain the integrity of the composition until use isdesired.

[0013] The apparatus is configured for receipt in an external forceapplying member, for example, a handle with a spring loaded shaft, in atemporarily locking arrangement. When use is desired, the apparatussnaps or locks into the handle and the spring loaded shaft is moved intocontact with the plunger, pushing it, so as to push composition out ofthe tip into the periodontal pocket.

[0014] Another embodiment is directed to apparatus for dispensingmaterial. This apparatus is formed of a barrel with a plunger, at leasta portion of which is slideably housed in the barrel. The barrelincludes a body portion and a tube portion, the tube portion extendingfrom the body portion and including a tip configured for being deformedto at least one geometry different from its initial geometry. Theplunger is configured for contacting a portion of an external forceapplying member.

[0015] The apparatus is configured for receipt in an external forceapplying member, for example, a handle with a spring loaded shaft, in atemporarily locking arrangement. When use is desired, the apparatussnaps or locks into the handle and the spring loaded shaft is moved intocontact with the plunger in order to push it, to release a composition,previously loaded into at least the tip, out of the tip to the desiredsite.

[0016] Another embodiment is directed to a method for treatingperiodontal disease. This method involves providing an apparatuscomprising, a force applying member adapted for receiving a barrel of acartridge and a cartridge. The cartridge has a barrel including a bodyportion and a tube portion, the tube portion extending from the bodyportion, and the tube portion ends in a tip, that is configured forbeing deformed to at least one geometry different from its initialgeometry. There is also a plunger, at least a portion of the plungerslideably housed within the barrel, the plunger configured forcontacting a portion of the force applying member. There is also aquantity of dry particles, at least a portion of the dry particles beingwithin the tip. The force applying member and cartridge are then placedinto operative communication each other, for example, by a temporarylocking engagement. The tip is then deformed, for example, to asubstantially flattened geometry, and the deformed tip is moved into atleast one periodontal pocket. The force applying member can have aportion of it (e.g., a spring-loaded shaft), moved to contact theplunger, moving the plunger so as to deliver the composition to the atleast one periodontal pocket.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Attention is now directed to the drawing figures, where likereference numerals or characters indicate corresponding or likecomponents. In the drawings:

[0018]FIG. 1 is side view of the apparatus disclosed herein;

[0019]FIG. 2 is a cross sectional view of the sleeve of FIG. 1 with thefinger rest removed;

[0020]FIG. 3 is a cross-sectional view of the shaft and associatedcomponents of FIG. 1;

[0021]FIG. 4 is a top view of the cartridge of FIG. 1;

[0022]FIG. 5A is a cross-sectional view taken along line 5-5 of thecartridge of FIG. 4 with the plunger in a first position;

[0023]FIG. 5B is a cross-sectional view taken along line 5-5 of thecartridge of FIG. 4 with the plunger in a second position;

[0024]FIG. 5C is a cross-sectional view taken along line 5-5 of thecartridge of FIG. 4 with the plunger in a first position but lackingwith the cap and composition removed;

[0025]FIG. 6 is a perspective view of the plunger of the apparatus;

[0026]FIG. 7 is a cross-sectional view of the plunger of the apparatus;

[0027]FIG. 8 is a rear view of the plunger of the apparatus;

[0028]FIG. 9 is a cross sectional view of the end segment of the plungerof FIG. 7;

[0029]FIG. 10 is a perspective view of an alternate cartridge barrel forthe apparatus of FIG. 1;

[0030]FIG. 11 is a cross-sectional view of the cartridge barrel of FIG.10;

[0031] FIGS. 12-14 are perspective views detailing operation of theapparatus of FIG. 1;

[0032]FIG. 15 is a cross-sectional view of the apparatus of FIG. 1 withthe cartridge in the locked position;

[0033]FIGS. 16A and 16B are perspective views of the tip of theapparatus of FIG. 1 during operation of the apparatus of FIG. 1;

[0034]FIG. 17 is a perspective view of the cartridge with a flattenedtip of the apparatus of FIG. 1 entering a periodontal pocket inoperation;

[0035]FIG. 18 is a view of the tip of the cartridge in a periodontalpocket, the tip exaggerated to illustrate operation of the apparatus ofFIG. 1;

[0036]FIG. 19 is an alternate operation for the cartridge of theapparatus of FIG. 1, where the tip is deformed upon contact with theteeth or surrounding tissues; and

[0037]FIG. 20 is a cross-sectional view of the apparatus of FIG. 1 withthe cartridge being unlocked for its removal from the handle.

DETAILED DESCRIPTION OF THE DRAWINGS

[0038]FIG. 1 shows an apparatus 20 formed from a handle 22 and acartridge 24 that connects to the handle 22 and is separable therefrom.The cartridge 24 is typically disposable, and for example, is preloadedwith a composition or substance, for example, a therapeutic agent(s) orthe like, as detailed below. While a single cartridge 24 is shown, thiscartridge 24 is exemplary only, as multiple cartridges are typicallyused one after the other in a typical procedure, as the therapeuticagent in each cartridge is exhausted. The end of the cartridge 24 istypically covered by a cap (or covering member) 30 (typically with aperipheral ring 31 to facilitate gripping by the dental professional) orother closing member, typically in a frictional engagement, thatmaintains the integrity of the composition in the cartridge 24 untilactual use, when this cap 30 is removed.

[0039] The handle 22 is of a configuration and dimensions similar toother dental instrumentation. The handle 22 is formed of a sleeve 40,with a fingergrip 42 surrounding it. A thumb ring 44, connected to aspring loaded shaft 46, extends from the sleeve 40, with the shaft 46held in place by a nut member 48, that includes a threaded portion 50(FIG. 3) that connects to a correspondingly threaded portion 51 (FIG. 2)on the inner wall 52 (FIG. 2) of the sleeve 40. The nut member 48, on aproximal portion 48 a (FIG. 3), includes a roughened, knurled or groovedouter surface 54, to assist the user in gripping, when opening thehandle 22 is desired.

[0040] Turning also to FIGS. 2 and 3, the handle 22 is separated intothe sleeve 40 (FIG. 2) and the shaft 46 and associated components (FIG.3). The sleeve 40 includes a proximal end 60 and a distal end 61. Theproximal end 60 includes a threaded portion 51 along its inner wall 52,for accommodating the correspondingly threaded portion 50 on anintermediate 48 b portion of the nut member 48. Moving distally (in adirection away from the thumb ring 44), there is a section 64 foraccommodating the spring 88 and its proximal confinement 86 and distalconfinement 90, specifically its head 90 a. This spring section 64chamber includes a reduced diameter portion 66, that serves as a stopsurface for the head 90 a of the distal confinement 90, when the shaft46 is pushed distally by the thumb ring 44.

[0041] The distal end 61 includes a notch (or indent) 70 at the outeredge 71 of the sleeve 40, for receiving a corresponding nub 130 (FIG. 4)on the cartridge 24, to prevent the cartridge 24 from rotating in thesleeve 40 (of the handle 22) when the cartridge 24 (in particular, itsflanges 128, see FIG. 4) is locked in place in the handle 22, asdetailed below. Proximal of this notch 70 is a chamber 72 foraccommodating the flanges 128 of the cartridge 24 as pushed outward bythe body 90 b of the distal confinement 90. The chamber 72 terminates ata groove 74 that typically extends continuously around the inner wall 52of the sleeve 40. The groove 74 is typically triangular in its edges 76,to accommodate the corresponding protrusions 136 (FIG. 4) on the flanges128 (FIG. 4) of the cartridge 24, upon their seating therein, when thecartridge 24 is locked in the handle 22.

[0042] These triangular edges 76 allow for removal of the cartridge 24from the handle 22, as the protrusions 136 of the flanges 128 can slideover these surfaces 76, allowing for the release of the cartridge 24, asdetailed below. A section 80 for accommodating the body 90 b of thedistal confinement 90 is intermediate the groove 74 and the springchamber 64.

[0043] The shaft 46 extends (in the distal direction) from the thumbring 44 to the shaft end 84 (distal end). The nut member 48, proximalconfinement 86, spring 88 and distal confinement 90 (formed of a head 90a and a body 90 b) are all torroidal and slideable on the shaft 46. Whenthe nut member 48 is attached to the sleeve 40 (so as to be fixed), inits normal operation, the nut member 48, at its distal portion 48 c,serves as a confinement for the proximal confinement 86, when the shaft46, typically via the thumb ring 44, is moved in the proximal direction(outwards with respect to the sleeve 40). The shaft 46 includes anoutwardly extending ring 92 at its distal end 84. This ring 92,typically molded as part of the shaft 46, is fixed, and serves to limitdistal movement of the distal confinement 90 for the spring 88.

[0044] Handle 22 and all components thereof, except the spring 88, istypically made of materials such as metals and in particular surgicalgrade steels, for example, 303 Stainless Steel. The spring 88 istypically made of metals such as surgical grade steels, and for example,stainless steels other then 303 Stainless Steel. Accordingly, the handle22, including the spring 88, is sterilizable and reusable. Handlecomponents may also be made by injection molding of suitable resins.

[0045]FIGS. 4, 5A and 5B show the cartridge 24, as formed of a barrel100. The barrel 100 has a body portion 104 and a tube portion 106, inwhich a plunger 108 is fitted, for sliding therein. The plunger 108includes a head 114 for movement within the body portion of the barrel100, and a tail 116, for movement in the tube portion 106 of the barrel100.

[0046] The tube portion 106 is typically angled, at an angle Θ, that isfor example, approximately 40 to 60 degrees, and for example, inparticular approximately 50 degrees, to provide the dental professional(clinician) with easy access to the periodontal pockets. The plunger108, enclosed within the barrel 100 is curved similarly. There may beprotrusions 118 on the outer surface 119 of the barrel 100, to provide atactile indication of a gripping area for the cartridge 24.

[0047] The body portion 104 is typically a cylindrical segment 120, withan inwardly tapered portion 122 to the tube portion 106, and a collar124, at the opposite end. Flanges 128 extend from the collar 124. Thecollar 124 has an inner diameter diameter less than the inner diameterof the sleeve 40 (between the inner walls 52 a) of the handle 22, thiscollar inner diameter extending to an outer diameter that is greaterthan this sleeve, such that the collar surface 124 a abuts the edge 71of the sleeve 40, so as to limit movement of the cartridge 24, and inparticular, prevent the cylindrical segment 120 from moving into thesleeve 40 of the handle 22. For example, the outer diameter of thecollar 124 is equal to or slightly greater than the outer diameter ofthe sleeve 40 of the handle 22, such that the cartridge 24 and handleare flush along their outer surfaces.

[0048] A nub 130 protrudes from the collar 124. This nub 130 iscorrespondingly shaped, for example, semicircular here, with respect tothe notch 70 in the handle 22, for seating therein, to prevent rotationof the cartridge 24. This nub 130 could also be any other shape providedthat upon seating in the notch 70, typically correspondingly shaped,such that the seating will prevent rotation of the cartridge 24. The nub130 is for example, positioned approximately 180 degrees with respect tothe bending of the tube portion 106, for ease of access to theperiodontal pocket by the dental professional. However, any otherpositioning is also suitable.

[0049] The flanges 128 extend from the collar 124. These flanges 128,based on the resilience of the material of the barrel 100, are flexible,and are designed to move radially outward and inward. Protrusions 136extend from the outer surfaces 128 a of each of the flanges 128. Theseprotrusions 136 are typically rounded (but could also be triangular orany other shape that allows for sliding easily out of the grooves 74)and configured for seating into the groove 74 of the handle 22, so as tocreate a locking engagement of the cartridge 24 in the handle 22. Here,for example, four flanges 128 are shown in a cylindrical (rounded)orientation, to correspond in shape to the sleeve 40 and distalconfinement body 90 b of the handle 22. However, any number of flanges128 is suitable, provided the locking engagement of the cartridge 24 inthe handle 22 can be attained.

[0050] Turning also to FIG. 5C, the tube portion 106 terminates at a tip140, that tapers inward. This inward tapering (distally) provides thetip 140 with reduced inner wall 142 thickness, allowing the tip 140,with its initially circular opening 146 and cylinder shape, to changegeometries, and flatten out, such that the opening 146 and the tip 140deform, typically into an oval shape (in cross section) and thus, thetip 140 flattens. This changing in geometries is done by manualmanipulation by the dental professional (prior to use) or upon contactwith a tooth or other tissue. This flattening provides greateraccessibility and maneuverability of the tip 140 in the periodontalpocket, as detailed below.

[0051] The tube portion 106 includes a ring protrusion 150 proximate thetip 140 that serves in frictionally retaining the cap 30 on the tubeportion 106 (over the tip 140), prior to its removal, when use of thecartridge 24 is desired.

[0052] An amount of a composition 154 is typically placed (preloaded)into the tip 120 (and if necessary into the tube portion 106). Thiscomposition is typically a particulate composition, such as a drymicroparticle composition in a sufficient treatment quantity. Forexample, the composition can be ARESTIN™ minocycline Hydrochloride (HCl)microspheres, from OraPharma, Inc., 732 Lewis Drive, Warminster, Pa.18974, for example, in a 1 mg dosage, or those compositions as disclosedin U.S. Pat. Nos. 5,000,886, 5,143,661, 5,236,355, 5,366,733, 5,500,228,and 5,622,498, all six disclosures of which are incorporated byreference herein. These compositions can be dispersed in matricies ofbiocompatible and biodegradable polymers, in accordance with thedisclosure of U.S. Pat. No. 5,622,498.

[0053] For example, dry microparticle compositions may includetherapeutic agents, such as antibacterials, antibiotics, antifungalagents, anti-inflammatory agents, immunosuppressive agents,immunostimulatory agents, dentinal desensitizers, odor masking agents,immune reagents, anesthetics, antiseptics, nutritional agents,antioxidants, lipopolysaccharide complexing agents, peroxides, tissuegrowth factors, or mixtures thereof. The therapeutic agent could alsohave antibiotic activity.

[0054] Exemplary therapeutic agents may be antibiotics such astetracycline, a pharmaceutically acceptable salt of a tetracycline,hydrates of a tetracycline and hydrates of a pharmaceutically acceptablesalt of a tetracycline. The tetracyclines may be doxycycline, apharmaceutically acceptable salt of doxycycline, hydrates of doxycyclineand hydrates of a pharmaceutically acceptable salt of doxycycline. Also,the tetracycline may be minocycline, a pharmaceutically acceptable saltof minocycline, hydrates of minocycline and hydrates of apharmaceutically acceptable salt of minocycline.

[0055] These exemplary therapeutic agents are in the form of particlesand in particular, dry particles. They can typically range from about0.00001 to about 50 parts by weight per 100 parts by weight of theparticles or from about 1 to about 50 parts by weight per 100 parts byweight of the particles, or more particularly from about 4 to about 40parts by weight per 100 parts by weight of the particles.

[0056] For example, polymers for the aforementioned matricies mayinclude polyglycolide, poly(1-lactide), poly(dl) lactide, poly(glycolide-co-lactide), poly (glycolide-co-dl lactide), poly (alphahydroxybutyric acid, poly(orthoesters), poly (p-dioxanone) and mixturesthereof. The polymers can also be block copolymers of polyglycolide,trimethylene carbonate and polyethylene oxide. These polymers may alsobe such that they become tacky upon contact with water.

[0057] The aforementioned particles of particulate compositionsincluding therapeutic agents, may for example, have particles withdiameters ranging from about 0.1 to about 1000 microns, andspecifically, from about 10 to about 200 microns, and more specifically,from about 30 to about 120 microns.

[0058] The barrel 100 of the cartridge 24 is of, for example, as anintegral unit, of, for example, polymers, such as olefin homopolymers orcopolymers or mixtures thereof, such as polypropylene (e.g., MONTELLPD-626 Polypropylene), or polyethylene. It is typically formed bytechniques such as injection molding or the like. The bending (curving)of the tube portion 106 is performed in a separate step, after theinjection molding. The cap 30 is typically of a polymeric material suchas polypropylene, and it may be colored, so it can be easilydifferentiated from the tube portion 106.

[0059] The plunger 108 is enclosed within the barrel 100, in africtionally tight but slideable engagement. FIG. 5A details the plunger108 in a first position, prior to use, while FIG. 5B details the plunger108 in a second or post use position (after the plunger 108 has beenpushed its requisite distance by the shaft 46 of the handle 22, asdetailed below). The inwardly tapered portion 122 of the cylindricalsection 120 serves as a travel limit for the plunger 108.

[0060] Turning to FIGS. 6-9, the plunger 108 is shown in detail. Inthese figures, the plunger 108 is shown straight and not bent or angled.This is for description purposes, as the plunger 108, when loaded intothe barrel 100 will conform to the shape of the barrel 100.

[0061] The head 114 and tail 116 portions of the plunger 108 arecorrespondingly configured with respect to the body 104 and tube 106portions of the barrel 100, where they reside.

[0062] Turning also to FIG. 8, the head portion 114 is formed of slats166, typically with a discontinuous distal outer surface 166 a, 166 b.These slats 166 extend from a core 168, that has a central surface 170,typically flush with the proximal outer surfaces 166 c of the slats 166.This central surface 170 is a contact surface for the distal end 84 ofthe shaft 46, that abuts it when movement of the plunger 108 to releasecomposition 154 is desired. The head portion 114 slip fits into the bodyportion 104 of the barrel 100, resting loosely therein. The slats 166prevent a gross misalignment of the central surface 170 and distal end84 of the shaft 46. A trunk segment 174 of the head portion 114 servesas a limit of travel for the plunger 108 in the body portion 104 of thebarrel 100 when the head portion 114 is pushed (distally) by the distalend 84 of the shaft 46.

[0063] The tail portion 116 extends from the trunk segment 174. The tailportion 116 includes a first segment 176, an intermediate segment 178and an end segment (distal end segment) 180. The first segment 176 istapered and thickened, for example, to have an outer diameter thatprovides the plunger 108 with strength while avoiding the tendency tobend (bow) or kink if excess pressure is applied by the shaft distal end84 of shaft 46 of the handle 22. The intermediate segment 178 is of alesser diameter less than or equal to that of the first segment 176.

[0064] The end segment 180 is outwardly tapered (distally) to an edgesurface 182, as shown in FIG. 9. This edge surface 182 is typically of adiameter greater, typically slightly greater, than the inner diameter ofthe tip 140, such that it contacts the inner walls 142 of the tip 140.This contact, typically is an interference fit, to provide the frictionfit necessary to retain the plunger 108 in the barrel 100, whileallowing the plunger 108 to slide in the barrel 100. It also allows forthe composition 154 to be wiped cleanly off of the inner walls 142 ofthe tip 140, such that the composition is pushed (distally) out of thetip 140 (through the opening 146) to the treatment site, keeping thecomposition 154 from moving backwards (proximally) in the tube portion106, or alternately keeping the composition from moving between the endsegment 180 and inner walls 142 leading to jamming of the plunger 108.

[0065] The plunger 108 is typically an integral member, and made ofmaterials such as polymers, for example, olefin homopolymers, olefincopolymers, and polycarbonate (e.g., Bayer® 2458-1117-Polycarbonate).The plunger 108 is formed by techniques such as injection molding or thelike. The plunger 108 is typically of a polymer different than thosepolymers for the cartridge 24, so as to provide the plunger 108 with theability to move smoothly between the aforementioned first (FIG. 5A) andsecond (FIG. 5B) positions.

[0066]FIGS. 10 and 11 show an alternate embodiment of the cartridge 224,in particular the barrel portion 100′ (the plunger is not shown). Thisembodiment is similar in all aspects to the cartridge 24 detailed above,except that the tube portion 106′ (similar to tube portion 106) and thecorresponding plunger are straight and not bent. All other aspects ofconstruction and arrangement of components are similar to those detailedabove and are thus, numbered similarly.

[0067] FIGS. 12-20 detail exemplary operations of the apparatus 20.Initially, as shown in FIG. 12, multiple cartridges 24, for exampletwelve, are packaged in a tray 300. The tray 300 with cartridges 24 istypically packaged with desiccant in a heat-sealed foil laminatedresealable pouch (not shown). The foil laminate for example, can be analuminum or other foil laminate in accordance with the foil laminatedisclosed in U.S. Pat. No. 5,622,498, incorporated by reference herein.The microparticles in each cartridge 24 may be provided in sterile formby aseptic manufacturing techniques or by terminal sterilization, forexample, by gamma radiation, after being loaded into the respectivecartridges 24 and packaged in a pouch.

[0068] A first hand 302 of the dental professional grips the tray 300,while a second hand 304 grips the handle 22. A cartridge 24 is thenremoved from the tray 300, and moved in the direction of arrow 306toward the handle 22, as shown in FIG. 13. Movement in the direction ofarrow 306 continues until the cartridge 24 enters the sleeve 40 of thehandle 22, defining the apparatus 20 and locks in place, as shown inFIG. 14. The handle 22 now rests comfortably in the hand 304 of thedental professional with the thumb 310 extending through the thumb ringand fingers 312 on the finger grip 42 for proper maneuvering. The cap 30has now been removed.

[0069] Turning to FIG. 15, the locking of the cartridge 24 in the sleeve40 is shown in detail. Here, the cartridge 24 has been pushedproximally, as the handle 22 remains at rest, as the thumb ring 44 is atthe at rest distance D from the sleeve 40. The inward or proximalpushing of the cartridge 24 causes the flanges 128 to abut the body 90 bof the distal confinement 90, whereby the flanges 128 spread radiallyoutward. Inward movement continues, until the nub 130 seats in the notch70 (inward movement is made with nub 130 and notch in alignment) and theprotrusions 136 engage the groove 74. This is typically noticedtactilely as well as an auditory “click” can be detected.

[0070] Additionally, the plunger 108 aligns with the shaft end 84,whereby the shaft end 84 contacts the central surface 170. The plunger108 is in the first position, as shown in FIG. 5A. Throughout thisattachment process, distal resistance is provided by the spring 88.Locking of the cartridge 24 is complete, as the nub 130 is seated in thenotch 70, the collar 124 is close to or in abutment with the edge 71 ofthe sleeve 40, and the protrusions 136 of the flanges 128 are seated inthe groove 74.

[0071] The tip 140, with the composition 154 therein, is in its normalor at rest geometry, with a circular or substantially circular openingand cross section, as shown in FIG. 16A. The dental professional can nowmanually deform the tip 140, typically by flattening it with aninstrument. This flattening results in the opening 146 and the tip 140having oval or flattened shape (and geometry), as shown to in FIG. 16B.

[0072] The dental professional, familiar with thumb ring handle devices,can now maneuver the apparatus 20, in particular the tip 140 of the tubeportion 106 of the cartridge 24 of the apparatus 20 to the periodontalpocket 320, between the tooth 322 and gum 324, as shown in FIG. 17.Here, the tip 140, that is now flattened, can be maneuvered deep intothe periodontal pocket 320 (for emphasis, being the mark labeled P),between the tooth 322 and gun 324.

[0073] In FIG. 18, the composition 154 can now be released into thepocket. Here, turning also to FIG. 15, the thumb ring 44 is moveddistally (toward the sleeve 40), such that the shaft 46 and distal tip84 thereof moves distally, forcing the plunger 108 distally, ultimatelyto the second position shown in FIG. 5B, to force composition 154 out ofthe tip 140 through the opening 146 and into the pocket 320.

[0074] Alternately, returning to FIG. 16A and its accompanyingdescription, the dental professional can maneuver the apparatus 20 so asto abut the tooth 322 or gum 324, as shown in FIG. 19. This abutment,typically coupled with movement into the periodontal pocket 320 willcause the tip 140 to deform its shape, becoming flatter, to reach deeperinto the periodontal pocket 320 (beyond the mark labeled P), as shown inFIG. 17. The process continues, as described for FIGS. 17 and 18 above.

[0075] Returning to FIG. 18, for both operations, with the cartridge 24,and in particular the tip 140, exhausted of composition 154, theapparatus 20 is manipulated, such that the cartridge is removed from theperiodontal pocket 320, in the direction of the arrow 330.

[0076] Attention is now directed to FIG. 20. Here, the cartridge 24 hasbeen exhausted as the plunger 108 is in the second position, as shown inFIG. 5B above. The spring 88 has caused the distal end 84 of the shaft46 to move out of contact with the central surface 170 of the plunger108, as the distal end 84 moves proximally toward the thumb ring 44, andreturn to the at rest position of the handle 22.

[0077] The thumb ring 44 is pulled proximally (away from the sleeve 40),a distance D plus an additional distance n, expressed D+n. The spring 88is compressed, as this proximal pulling takes the body 90 b of thedistal confinement 90 out of abutting contact with the flanges 128,allowing them to spring back, moving radially inward, to their rest ornormal positions. The protrusions 136 of the flanges 128 no longer seatin the groove 74, but rather just slightly extend into the groove 74.This allows for easy manual removal of the cartridge 24 from the handle22, while the cartridge 24 is retained in an engagement with the handle22, should the handle 22 be pointed downward, so the cartridge 24remains in and does not fall out of the handle 22. This ease in removalis accomplished as the rounded edges of the protrusions 136, coupledwith the triangular edges 76 of the grove 74, allow for the cartridge 24to be easily pulled out of the sleeve 40 with minimal force. Once thecartridge 24 is removed from the handle 22, the process may be repeatedwith additional cartridges for as long as desired.

[0078] While preferred embodiments of an apparatus, components andmethods, have been described above, the description of the apparatus,components and methods above is exemplary only. Those skilled in the artwill recognize, or be able to ascertain using no more than routineexperimentation, many equivalents to the specific embodiments of theinvention described herein. Such equivalents are intended to beencompassed by the following claims.

What is claimed is:
 1. An apparatus for dispensing at least one materialto a periodontal pocket comprising: a barrel including a body portionand a tube portion, the tube portion extending from the body portion andincluding a tip configured for being deformed to at least one geometrydifferent from its initial geometry; a plunger, at least a portion ofthe plunger slidably housed within the barrel, the plunger configuredfor contacting a portion of an external force applying member; and aquantity of dry particles, at least a portion of the dry particleswithin the tip.
 2. The apparatus of claim 1, wherein the dry particlescomprise at least one therapeutic agent.
 3. The apparatus of claim 2,wherein the dry particles comprise an effective amount of the at leastone therapeutic agent, the therapeutic agent dispersed in a dry matrixcomprising a biocompatible and biodegradable polymer.
 4. The apparatusof claim 2, wherein the therapeutic agent is selected from the groupconsisting of an antibacterial, an antibiotic, an antifungal agent, ananti-inflammatory agent, an immunosuppressive agent, animmunostimulatory agent, a dentinal desensitizer, an odor masking agent,an immune reagent, an anesthetic, an antiseptic, a nutritional agent, anantioxidant, a lipopolysaccharide complexing agent, a peroxide, a tissuegrowth factor or mixtures thereof.
 5. The apparatus of claim 2, whereinthe therapeutic agent has antibiotic activity.
 6. The apparatus of claim5, wherein the therapeutic agent comprises an antibiotic selected fromthe group consisting of a tetracycline, a pharmaceutically acceptablesalt of a tetracycline, hydrates of a tetracycline and hydrates of apharmaceutically acceptable salt of a tetracycline.
 7. The apparatus ofclaim 6, wherein the tetracycline is selected from the group consistingof doxycycline, a pharmaceutically acceptable salt of doxycycline,hydrates of doxycycline and hydrates of a pharmaceutically acceptablesalt of doxycycline.
 8. The apparatus of claim 6, wherein thetetracycline is selected from the group consisting of minocycline, apharmaceutically acceptable salt of minocycline, hydrates of minocyclineand hydrates of a pharmaceutically acceptable salt of minocycline. 9.The apparatus of claim 2, wherein the therapeutic agent comprises fromabout 0.00001 to about 50 parts by weight per 100 parts by weight of theparticles.
 10. The apparatus of claim 3, wherein the polymer is selectedfrom the group consisting of polyglycolide, poly(l-lactide), poly(dl)lactide, poly (glycolide-co-lactide), poly (glycolide-co-dl lactide),poly (alpha hydroxybutyric acid, poly(orthoesters), poly (p-dioxanone)and mixtures thereof.
 11. The apparatus of claim 3, wherein the polymercomprises a block copolymer of polyglycolide, trimethylene carbonate andpolyethylene oxide.
 12. The apparatus of claim 3, wherein the polymerbecomes tacky upon contact with water.
 13. The apparatus of claim 1,wherein the particles have a diameter of from about 0.1 to about 1000microns.
 14. The apparatus of claim 13, wherein the microparticles havea diameter of from about 10 to about 200 microns.
 15. The apparatus ofclaim 14, wherein the microparticles have a diameter of from about 30 toabout 120 microns.
 16. The apparatus of claim 9, wherein the therapeuticagent comprises from about 1 to about 50 parts by weight per 100 partsby weight of the particles.
 17. The apparatus of claim 16, wherein thetherapeutic agent comprises from about 5 to about 40 parts by weight per100 parts by weight of the particles.
 18. The apparatus of claim 1,wherein the barrel comprises a polymer selected from the groupconsisting of olefin homopolymers, olefin copolymers and mixturesthereof.
 19. The apparatus of claim 1, wherein the plunger comprises apolymer selected from the group consisting of olefin homopolymers,olefin copolymers and polycarbonates.
 20. The apparatus of claim 18,wherein the olefin homopolymer or copolymer comprises a polymer selectedfrom the group consisting of polyethylene and polypropylene.
 21. Theapparatus of claim 2, wherein the at least one therapeutic agentincludes minocycline Hydrochloride.
 22. The apparatus of claim 1,wherein the body portion includes flexible flanges for forming atemporary locking engagement with at least a portion of an externalforce applying member.
 23. The apparatus of claim 22, wherein the bodypotion includes at least one nub for receipt in a correspondinglyconfigured indent in at least a portion of an external force applyingmember to prevent the barrel from rotating.
 24. The apparatus of claim23, additionally comprising: an external force applying member.
 25. Theapparatus of claim 24, wherein the external force applying memberincludes a handle.
 26. The apparatus of claim 25, wherein the handleincludes: a sleeve including an indent for engaging the at least one nubof the barrel; a spring-loaded shaft housed at least partially withinthe sleeve; the sleeve and the shaft configured to engage a at least aportion of each of the flexible flanges of body potion of the barrel.27. The apparatus of claim 26, wherein the spring-loaded shaft includes:a proximal end and a distal end; and a thumb ring at the proximal end.28. The apparatus of claim 1, additionally comprising: a removableclosure configured for covering at least a portion of the tip tomaintain the integrity of the dry particles.
 29. The apparatus of claim1, enclosed in a package.
 30. The apparatus of claim 29, wherein thepackage comprises an aluminum-laminate pouch.
 31. The apparatus of claim29, wherein the package is resealable.
 32. The apparatus of claim 1,enclosed in a sterilizable package.
 33. The apparatus of claim 32,wherein the sterilizable package comprises an aluminum-laminate pouch.34. The apparatus of claim 1, wherein the barrel and the plunger areformed of radiation sterilizable materials.
 35. An apparatus fordispensing material comprising: a barrel including a body portion and atube portion, the tube portion extending from the body portion andincluding a tip configured for being deformed to at least one geometrydifferent from its initial geometry; and a plunger, at least a portionof the plunger slideably housed within the barrel, the plungerconfigured for contacting a portion of an external force applyingmember.
 36. The apparatus of claim 35, wherein the body portion includesflexible flanges for forming a temporary locking engagement with atleast a portion of an external force applying member.
 37. The apparatusof claim 36, wherein the body potion includes at least one nub forreceipt in a correspondingly configured indent in at least a portion ofan external force applying member to prevent the barrel from rotating.38. The apparatus of claim 36, additionally comprising: an externalforce applying member.
 39. The apparatus of claim 38, wherein theexternal force applying member includes a handle.
 40. The apparatus ofclaim 39, wherein the handle includes: a sleeve including an indent forengaging the at least one nub of the barrel; a spring-loaded shafthoused at least partially within the sleeve; the sleeve and the shaftconfigured to engage a at least a portion of each of the flexibleflanges of body potion of the barrel.
 41. The apparatus of claim 40,wherein the spring-loaded shaft includes: a proximal end and a distalend; and a thumb ring at the proximal end.
 42. A method for treatingdental disease comprising: providing an apparatus comprising: a forceapplying member adapted for receiving a barrel of cartridge; a cartridgecomprising: a barrel including a body portion and a tube portion, thetube portion extending from the body portion and including a tipconfigured for being deformed to at least one geometry different fromits initial geometry; a plunger, at least a portion of the plungerslideably housed within the barrel, the plunger configured forcontacting a portion of the force applying member; and a quantity of dryparticles, at least a portion of the dry particles within the tip;placing the force applying member into operative communication with thecartridge; deforming the tip to a substantially flattened geometry; andmoving the deformed tip into at least one periodontal pocket.
 43. Themethod of claim 42, additionally comprising: delivering the compositionto the at least one periodontal pocket.
 44. The method of claim 43,wherein delivering the composition to the periodontal pocket includes,moving the at least a portion of the force applying member to move theplunger, and releasing the composition from the tip.
 45. The method ofclaim 42, wherein the tip is deformed manually.
 46. The method of claim42, wherein the tip is deformed upon contact with a tooth or othertissue.